14 results · 21ms · Sources: EU EUDAMED, US FDA

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PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE

FDA 510(k)
FDA Class 2 ·Radiology

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606361·Sprint II Bracket Roth .018" 20 Brackets

FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT

FDA 510(k)
FDA Class 2 ·Ophthalmic

STRYKER TRAUMA PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CADD

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·March 23, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

CADD MEDICATION CASSETTE

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·July 14, 2022

CADD

FDA Adverse Event
Malfunction ·NULL·Product code FPA·August 17, 2021

CADD MEDICATION CASSETTES

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·June 6, 2022

OLYMPUS ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 26, 2013

AXIUM HELIX DETACHABLE COIL

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code HCG·June 13, 2008

9/10 COCR HEAD 28MM +0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 6, 2011

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012